BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

    MDR report key: 14487026 · Received May 24, 2022

    Report

    Report Number
    9610824-2022-00028
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    April 27, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED QUESTION MARK RESULTS AND A 1+ POSITIVE RESULT WITH THE ANTI-D OF THE IH-CARD ABO/D(DVI-)+REV. A1, B. ON THE IH-1000 INSTRUMENT. THE CUSTOMER OBSERVED THIS ISSUE WITH THE HEMOBIOSCIENCE CONTROL (HBC) #3. THIS CONTROL WAS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE IH-CARD ABO/D(DVI-)+REV. A1, B FOR INVESTIGATIONAL TESTING BUT LOG FILES OF THE AFFECTED INSTRUMENT WERE PROVIDED. THE INVESTIGATION OF THE DATA FILES IS STILL ONGOING, SO IS THE INVESTIGATION OF THE RETENTION SAMPLE IN OUR QUALITY CONTROL LABORATORY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED QUESTION MARK AND A 1+ POSITIVE RESULT WITH THE ANTI-D OF THE IH-CARD ABO/D(DVI-)+REV. A1, B. ON IH-1000. THE CUSTOMER OBSERVED THIS ISSUE WITH THE HEMOBIOSCIENCE CONTROL (HBC) #3. THIS CONTROL WAS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY VISUALLY CHECKED THEIR RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. DUE TO THE COMPLAINT CAUSE FURTHER TESTS WERE PERFORMED WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON THE IH-1000: 9 D- ANTIGEN NEGATIVE DONOR SAMPLES, 2 D-ANTIGEN POSITIVE DONOR SAMPLE AND THE HBC #1-3 WERE TESTED WITH THE RETENTION SAMPLE. RESULT: NO IRREGULARITIES.WERE OBSERVED. HBC #3 (RHD NEGATIVE) WAS TESTED FOUR TIMES: ONE REACTION IN THE ANTI-D WELL WAS ASSESSED AS 1+ POSITIVE AND ONE AS QUESTION MARK. BOTH ASSESSMENTS WERE CORRECT DUE TO SOME SMALL RED DOTS / AGGLUTINATES. ALSO, 7 D- ANTIGEN NEGATIVE DONOR SAMPLES WERE TESTED IN 14 TIMES DETERMINATION ON THE IH-1000, SO THAT A TOTAL OF 98 CARDS WERE TESTED. ALL REACTIONS WERE CORRECT. THE REACTIONS IN THE GEL COLUMNS DID NOT SHOW ANY NOTICEABLE CHARACTERISTICS AND WERE CLEARLY EVALUATED AS NEGATIVE BOTH BY THE DEVICE AND VISUALLY. REGARDING THE AFFECTED IH-1000 INSTRUMENT, THE IMAGES OF THE DEVICE WERE ANALYZED. THE ANALYSIS SHOWED A HIGH TEXTURE ON THE ANTI D WELLS IDENTIFIED BY THE ALGORITHM IMAGE ANALYSIS. WE COULD DEDUCE THE 1+ INTERPRETED WAS CONFIRMED AND JUSTIFIED. THE CAMERA AND THE READING WERE CORRECTLY ADJUSTED. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION AND WHEN TESTING THE RETENTION SAMPLE, WE SOMETIMES OBSERVED RED BLOOD CELL RESIDUES ON THE LEFT SIDE OF GEL COLUMN. THESE RESULTS WERE ONLY OBSERVED WITH THE HEMOBIOSCIENCE CONTROL HBC #3, BUT NOT WITH DONOR SAMPLES. THE ANALYSIS OF THE DATA FILES CONFIRMED THE CORRECT ASSESSMENT OF THE IH-1000. THE READING AND THE CAMERA WERE CORRECTLY ADJUSTED. HOWEVER, THE SECTION INTERPRETATION OF RESULTS OF THE INSTRUCTION FOR USE CONTAINED THE FOLLOWING NOTE:" *A VERY WEAK REACTION IS NOT AN EXPECTED RESULT FOR ANTIGEN TESTING. IT MAY INDICATE THAT A FALSE POSITIVE OR A VERY WEAK/PARTIAL EXPRESSION OF THE ANTIGEN IS PRESENT. FURTHER INVESTIGATION OF THIS SAMPLE SHOULD BE PERFORMED BEFORE THE ANTIGEN STATUS IS DETERMINED." A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES, WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BUT DUE TO THE ISSUE OF THE HEMOBIOSCIENCE CONTROL ON THE IH-CARD WE INITIATED FURTHER ACTIONS, DOCUMENTED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354744 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 9144010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IH-1000, SN (B)(6)| IH-1000, SN (B)(6)